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Corbus Pharmaceuticals Holdings, Inc.

Corbus Pharmaceuticals Holdings, Inc. Q3 FY2020 earnings call

November 10, 2020 · fiscal period ended 2020-09

EPS · actual vs est

$-12.91 / $-12.31Miss -4.9%

Revenue · actual vs est

$1.2M /
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Summary

Generated 2020-11-10

Management highlights

• Yuval noted the challenging third quarter with lenabasum studies in systemic sclerosis and cystic fibrosis not meeting primary endpoints, but lenabasum is active with valuable data on clinical benefit. • Barbara discussed post-hoc analyses showing clinical activity of lenabasum in scleroderma (improvement in lung function for those on established immunosuppressants) and cystic fibrosis (low pulmonary exacerbation rates in some regions). • Dermatomyositis is a key value driver for next year, with the Phase III DETERMINE study shortened to 28 weeks. • NIH-sponsored SLE study has enrolled 93 of 100 subjects, with top-line data expected in first half 2021. • Preclinical programs with CB2 agonists and new CB1 inverse agonists are highlighted, with focus on prioritizing programs for early data inflection points.

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Segment performance

No detailed segment performance by product with revenue contribution provided in the transcript. The focus is on lenabasum and pipeline development.

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Guidance

• Shortened the DETERMINE Phase III study for dermatomyositis from 1 year to 28 weeks to accelerate top-line data to spring 2021. • Anticipate top-line data from DM Phase III study in 2021 and data from SLE program next year. • Prioritizing pipeline programs for earliest data inflection points.

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Risks

• Drug development risks, including studies not meeting primary endpoints as seen in systemic sclerosis and cystic fibrosis trials. • Uncertainties in clinical trial outcomes and regulatory approvals for new studies.

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Q&A highlights

Q: About the dermatomyositis study, rationale for shortening and impact on conduct/powering?

A: Barbara explained that recent industry changes (shorter Phase III studies in dermatomyositis) led to shortening to 28 weeks. Blinded data shows ~85% improvement by Week 28, tradeoff not great, will provide inflection point sooner.

Q: Expand on CB1 inverse agonist 4001 limitations and next-gen compounds?

A: Barbara said 4001 was insoluble and had brain penetration issues. Next-gen compounds have better physical/chemical properties and no early concerns about brain accumulation.

Q: On systemic sclerosis trial, how to incorporate FVC findings into FDA label?

A: Barbara said they'll do additional data analysis, design new study, and work with regulators. Yuval added they'll engage with scleroderma experts and start regulatory path.

Q: On 4001 program, plans for multiple candidates or one?

A: Barbara said plan is to move the best-performing compound forward into clinical development, being conservative with resources.

View in transcript ↓

Key numbers

Reported versus consensus

Earnings calendar feed

MetricReportedConsensusDeltaPrior year
EPS$-12.91$-12.31-4.9%
Revenue$1.2M

Transcript

November 10, 2020

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Prior quarters

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